Regulatory Compliance Solutions
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RegOps Services To Streamline Regulatory Submissions
5/28/2024
Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).
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Highly Potent And Complex API Contract Manufacturing
4/23/2024
Equipped with a diverse array of scales, our seasoned experts possess the finesse and acumen necessary to tackle even the most intricate and potent API projects.
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Software To Automate And Digitalize Data Recording Steps In QC Workflows
5/2/2023
Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.
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Rapid Sterility Testing: Actionable Results In Less Than 5 Hours
6/20/2024
Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.
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Metrology Teams Collaborating With Waters
7/14/2022
Explore how we can collaborate and customize our service types to help reduce your workload, decrease instrument downtime, and maintain quality standards to meet regulatory requirements.
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Reduce Cost And Effort When Servicing Clinical Trials In Canada
2/6/2018
Contracting an in-country clinical depot helps bring costs and timelines under control.
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Cleanrooms And Equipment For CRISPR Drug Manufacturing
6/9/2023
Revolutionizing Gene Editing: Germfree's Pioneering Cleanroom Solutions Propel CRISPR Manufacturing Forward
Cleanroom requirements for CRISPR manufacturing necessitate strict adherence to particulate contamination and operational workflows, ensuring safety and product quality in this transformative field. Germfree’s expertise in providing specialized cleanroom solutions supports the effective production of CRISPR-based technologies and their delivery systems. Germfree provides application based fit-for-purpose facilities design to cater to the unique needs of this rapidly evolving sector.
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How Are You Addressing Site Expansions While Meeting Important Project Deadlines?
7/14/2022
Discover how our fully automated pipetting robot can help you increase repeatability and performance for both routine and complex laboratory workflows.
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Enhance Product Safety With A Non-Destructive Leak Testing System
10/29/2023
Versatile CCIT1 for a wide range of applications
The SpeedAir 3050 is your all-in-one solution for nonporous pharmaceutical applications. Whether your products are flexible or rigid, liquid or solid, the SpeedAir 3050 can swiftly and accurately test them all. With testing times as short as 30-45 seconds, it delivers results you can rely on, ensuring the integrity of your pharmaceutical containers.
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21 CFR Part 11 Pharmaceutical FDA Compliant Software
2/28/2023
Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?
Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.